QA/RA Manager

Rapidemic is seeking a QA manager to join our team and contribute to the development of next-generation in vitro diagnostic (IVD) devices. As an QA Manager you will take ownership of developing and implementing an ISO 13485 Quality Management System (QMS) for in vitro diagnostic devices, with the responsibility of establishing, maintaining, and continuously improving the system. This role offers significant technical responsibility and strategic impact, with the opportunity to build and shape our quality culture from the ground up.

• Job Title: QA manager
• Level: Senior
• Reports to: COO
• Type: Full-time position (40h/week).
• Location: BioPartner 3, Leiden Bioscience  Park, Zuid-Holland.
• Modality: On-site. 1 day/week remote possible.
• Contract: Temporary, 1 year contract with possible extension
• Start Date: As soon as possible. Latest August 2026

Rapidemic is a molecular diagnostic company based in Leiden, the Netherlands, founded in 2021 with the mission to make quality diagnostics accessible to all, worldwide. The company’s laboratory facilities and offices are located in the beating heart of the Leiden Bioscience Park, where our team of 15 scientists, engineers, quality and regulatory experts and management team works to raise the bar in infectious disease diagnostics.

Our product platform, RapiDetect^TM is the world’s first equipment-free molecular diagnostic test capable of diagnosing infections in a single visit with lab-grade accuracy. Our first product under development, RapiDetect^TM CT/NG, breaks down barriers to test for patients with a suspected sexually transmitted infection.

Join us in shaping a future where every individual can access the care they need. Be part of the team that’s changing the face of molecular diagnostics and shaping a healthier tomorrow. We're seeking a motivated R&D Engineer to join our team, shape the company’s trajectory and bring this device to patients in need. Let’s build the future together at Rapidemic!

• Lead completion and implementation of the QMS; establishing procedures, work instructions, and other related applicable documentation.
• Maintain and continuously improve the QMS to ensure compliance with applicable regulation.
• Establish and maintain Document Control, and Change Management processes, ensuring timely updates and cross‑functional alignment. ·
• Oversee creation and maintenance of all quality documentation such as procedures, work instructions, batch records, test reports, among others.
• Support regulatory submission strategies, ensuring QMS alignment with submission timelines.
• Lead clinical risk management and benefit-risk analysis documentation for regulatory submissions.
• Establish traceability between requirements, design, testing, and clinical evidence.
• Plan and execute internal audits, supplier audits, and readiness activities for Notified Body assessments. Manage audit schedules, findings, and corrective actions.
• Ensure effective CAPA management in a cross-functional team, including root cause analysis, corrective actions, and effectiveness checks.
• Lead the QA team, define roles, responsibilities and training plans.

• Educational Background:
• Bachelor’s or Master’s degree in Life Sciences or related field.
• Minimum 5-7 years of experience in QA/RA roles within regulated medical device or IVD(R), environments.

• Required Skills:
• IVDR Expertise — deep understanding of EU 2017/746, Annex II/III Technical Documentation, classification rules, performance evaluation requirements.
• ISO 13485 QMS Management — hands‑on experience maintaining and improving certified QMS systems.
• Hands-on experience building and/or auditing ISO 13485 QMS, demonstrating proficiency on design controls, V&V, risk management and CAPA.
• Experience leading QA teams or similar functions.
• Proficiency in creating and managing technical documentation.
• Experience with Notified Body audits and regulatory inspections.
• Demonstrated success managing CAPA, audits, and QMS processes.
• Excellent verbal and written communication in English.
• Attention to detail and a proactive attitude.

• Preferred Skills:

o   Professional certification such as CMQ/OE (Certified Manager of Quality and Org. Excellence), CQIA (Certified Quality Improvement Associate), or equivalent.

o   Previous experience with setting up a full QMS system for IVD products.

o   Risk Management (ISO 14971) — creation, maintenance, and review of risk management files, hazard analysis, and risk‑benefit evaluation.

o   CAPA & Nonconformance Management — root cause analysis (5 Why, Ishikawa), effectiveness checks, deviation handling.

o   Internal & Supplier Auditing — planning, executing, and documenting audits; experience with Notified Body assessments.

o   Technical Documentation Writing — ability to structure and maintain TD files, performance evaluation reports, and quality plans.

o   Supplier Quality Management — qualification, monitoring, and performance review of critical suppliers.

o   Data Analysis & Quality Metrics — KPI dashboards, trend analysis, complaint data evaluation.

o   Digital QMS Tools — experience with eQMS, LIMS, or other document management systems.

o   Experience in early-stage start-up environments and building systems from scratch.

o   Experience with molecular diagnostic devices.

o   Experience with FDA regulation

• A competitive salary.
• An incredible learning experience working in a growing start-up.
• A relaxed work atmosphere.
• The opportunity to explore and test your own ideas.
• A working experience in a European hub for life sciences innovation.
• A work experience in the diagnostics industry.
• A budget for training and personal development

Please apply only if you can be physically present in Leiden and start before August 2026.

If you believe you are the person we are looking for, then we look forward to receiving your applications before the 15h of June. Only applications submitted via this portal will be considered.